Medicare Secondary Payer Rules and Clinical Trials
Navigating MSP Rules and Reporting Requirements for Research Sponsors and Clinical Sites and Best Practices for Contracting
Recording of a 90-minute CLE webinar/teleconference with Q&A
Conducted on Wednesday, August 8, 2012
Recorded event now available
This CLE webinar will prepare healthcare counsel to apply Medicare secondary payor (MSP) rules to research sponsors and clinical sites, and provide guidance on the new MSP reporting requirements and practical contracting approaches.
Description
The Medicare Secondary Payer law sets the requirements for coordination of benefits between insurance and Medicare. Research sponsors and clinical sites need to understand the MSP rules and their application to clinical trials to appropriately allocate responsibility for coverage of subject injuries.
New reporting requirements under Sec. 111 of MMSEA include CMS' position that payments for healthcare expenses by clinical trial sponsors constitute liability self-insurance. Such payments, claims or potential claims require reporting by the responsible reporting entity.
The MSP and Sec. 111 requirements are complex and guidance is limited. Compliance presents an ongoing challenge for research sponsors and clinical sites. Language addressing the MSP and reporting requirements for clinical trial agreements, informed consent and HIPAA authorization should be carefully drafted.
Listen as our authoritative panel of healthcare attorneys examines how the MSP rules and the new MSP reporting requirements apply to research sponsors and clinical sites. The panel will offer best practices for contracting.
Outline
- Application of MSP rules to clinical trials
- Historical interpretation
- Current guidance
- Open issues
- New MSP reporting requirements
- Overview
- Application to research sponsors
- Impact on clinical sites
- Open issues
- Best practices for contracting
- Clinical trial agreements
- Informed consent
- HIPAA authorization
Benefits
The panel will review these and other key questions:
- What are the new MSP reporting requirements?
- How do the MSP rules apply to research sponsors and clinical sites?
- How should language for clinical trial agreements, informed consent and HIPAA authorization be revised?
Faculty
Eve M. Brunts, Partner
Ropes & Gray, Boston
She regularly advises clients on Medicare and Medicaid coverage, claims and payment requirements for a variety of services; Medicare and Medicaid managed care programs; the Medicaid drug rebate program; Medicaid state plan requirements; reimbursement for health care services in clinical trials; managed care contracting and state managed care laws; and federal and state fraud and abuse laws.
David Piatt, Managing Partner
Piatt Consulting and Medicare Consul Services, Albuquerque, N.M.
He is the former Program Director of the Medicare Secondary Payer Recovery Contract where he managed Medicare's national recovery efforts and participated in the development of the Mandatory Insurer Reporting requirements. He has been on the forefront of this issue and recently brokered a meeting between CMS and two major Clinical Trials Sponsors.
Ordering
Online CLE - Audio Recording
Includes streaming audio of full program plus handouts (available 24 hours after live program).
CLE:
Pre-approved for participatory or non-traditional/alternate format credit in: CA, HI*, NY*, WV*.
Pre-approved for self-study credit in: AK, AZ, MO, MT, TX*, VT, WA.
Upon request, also available in: CO, CT*, FL, GA, ID, KY, LA*, ME, NC, ND, NE, NH, NM, NV, OR*, SC, TN, UT, WI, WY. If you are applying for credit in one of these states, make sure to select those states when placing your order.
(*Indicates that Strafford must report attendance.)
Online CLE Audio $297.00
Available 24 hours after the live event
Recorded Event
Includes full event recording plus handouts (available after live seminar).
CLE: Pre-approved for self-study credit in: AK, AZ, CA, CT, HI, MO, MT, NY, TX*, VT, WA, WV. Upon request, self-study credit is also available in: CO, FL, GA, ID*, KY, ME, ND, NE, NH, NM, NV, OR, UT, WI, WY. If you are applying for self-study credit in one of these states, contact Strafford CLE at 1-800-926-7926 ext. 35 or CLE@straffordpub.com. (*Indicates that Strafford needs to process the CLE — see below to purchase this option.)
Webinar Download (Slide Presentation with Audio) $297.00
Available three business days after the live event
DVD (Slide Presentation with Audio) $297.00
plus $9.45 S&H
Available ten business days after the live event
MP3 Download (Audio with Slide PDFs) $297.00
Available 24 hours after the live event
CD (Audio with Slide PDFs) $297.00
plus $9.45 S&H
Available ten business days after the live event
Webinar/Teleconference
Strafford webinars/teleconferences offer several options for participation: online viewing of speaker-controlled PowerPoint presentations with audio via computer speakers or via phone; or audio only via telephone (download speaker handouts prior to the program). Please note that our webinars do not feature videos of the presenters.
Program Materials
Requires Adobe Reader 8 or later. Download Acrobat FREE.
Program Materials
Requires Adobe Reader 8 or later. Download Acrobat FREE.
CLE Credit
Strafford's live seminars qualify for CLE in every state that accredits webinars. They offer you a high quality, cost effective, and convenient CLE option, with no lost travel time or expenses.
Customer Reviews
I enjoyed the programs content and the speaker's perspectives.
Brenda Laigaie
Wade Goldstein Landau & Abruzzo
I liked the use of current court cases.
Robert Cundiff
Northwestern Memorial Hopsital
The interactive questions at the end added value to the educational topic discussed during the presentation.
Ralph H. Heninger
Heninger & Heninger
Excellent presentation.
Barry Jasilli
CVS Caremark
The seminar was very informative and detailed, and I enjoyed the different perspectives of the speakers.
Melanie Martin
Cozen O'Connor
Health Law Advisory Board
Partner
Arent Fox
Shareholder
Fredrikson & Byron
Partner
Faegre Baker Daniels
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo
Partner
Rivkin Radler
Principal
Ober Kaler
Partner
McDermott Will & Emery
Of Counsel
Foley & Lardner
Partner
Foley & Lardner
Shareholder
Buchanan Ingersoll & Rooney
Partner
Drinker Biddle & Reath
Our Guarantee
Strafford webinars and teleconferences are backed by our 100% Unconditional Money-Back Guarantee: if you are not satisfied with any of our products, simply let us know and get a full refund. For more information regarding complaints and refunds, please contact us at 1-800-926-7926 ext 10.